Abstract

The Controlled Environment Testing Association guide focuses on isolator applications that are appropriate for use in facilities that compound sterile preparations. Owing to the fact that there are no uniform industry standards for the manufacture of barrier isolators, the purpose of this guide is to increase pharmacists’ awareness of the need to establish procedures addressing issues unique to isolators. This article provides critical information on major design features of isolators, including airflow, flow control, dilution control, pressurization, clean zone classification, decontamination/disinfection, gloves/sleeves, closed system versus open system, pass-through considerations, and ergonomic considerations. In the future, Controlled Environment Testing Association will publish a guide—not a testing “standard”—for industry procedures for testing and commissioning isolators, as no published industry procedures are available at this time.

Related Keywords

• sterile preparations
• aseptic compounding
• barrier isolators
• Controlled Environment Testing Association
• controlled environment
• airflow
• barrier isolation
• CETA
• compounded sterile preparations
• engineering controls
• environmental controls
• ISO standards
• United States Pharmacopeia

Related Categories

• ENVIRONMENTAL
• QUALITY CONTROL